Back to resultsAnlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy
Primary Purpose
Nasopharyngeal Carcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- biopsy proved nasopharyngeal carcinoma;
- stage IVB according to American Joint Committee on Cancer(AJCC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;
- 18 years or older; without other malignancy;
- proper functioning of the major organs.
Exclusion Criteria:
- allergic to anlotinib;
- female within gestation period or lactation;
- patients received drug of other clinical trial within 4 weeks.
Sites / Locations
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anlotinib
Arm Description
Outcomes
Primary Outcome Measures
disease control rate
disease control rate
Secondary Outcome Measures
overall response rate
overall response rate
progression-free survival
progression-free survival
overall survival
overall survival
duration of response
duration of response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03906058
Brief Title
Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy
Official Title
Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
February 27, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma after failure of no less than second-line chemotherapy or targeted therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
All patients enrolled in the study will accept anlotinib treatment as a palliative treatment .
Primary Outcome Measure Information:
Title
disease control rate
Description
disease control rate
Time Frame
30 months
Secondary Outcome Measure Information:
Title
overall response rate
Description
overall response rate
Time Frame
30 months
Title
progression-free survival
Description
progression-free survival
Time Frame
30 months
Title
overall survival
Description
overall survival
Time Frame
30 months
Title
duration of response
Description
duration of response
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
biopsy proved nasopharyngeal carcinoma;
stage IVB according to American Joint Committee on Cancer(AJCC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;
18 years or older; without other malignancy;
proper functioning of the major organs.
Exclusion Criteria:
allergic to anlotinib;
female within gestation period or lactation;
patients received drug of other clinical trial within 4 weeks.
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy
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